PRINCIPLES OF ASSAY DEVELOPMENT

Prerequisites & course information

Requisites: PHM SCI 759 and ( PHM SCI 757 or 762 ) Course Designation: Grad 50% - Counts toward 50% graduate coursework requirement Repeatable for Credit: No Learning Outcomes: 1. Explain and apply the concepts, principles, and applications of the most commonly used biochemical and spectrophotometric assays used in drug development to quantify the activity of molecular targets and their modulators. Audience: Graduate 2. Recommend specific in vitro target assays based on the molecular target of choice and on the desired data output. Audience: Graduate 3. Compare and contrast cellular models, their applications and limitations, and propose assays that directly measure on-target activity. Audience: Graduate 4. Critique the use of various animal models when extrapolating pre-clinical data to clinical development. Audience: Graduate 5. Synthesize knowledge of biochemical, in vitro, and cellular assays to evaluate the validity, applications, and future developments of New Approach Methods (NAMs), according to the current FDA guidelines for animal use in research. Audience: Graduate 6. Analyze critically experimental approaches, assays outcomes, and their alignment to experimental hypothesis in drug development projects within the broad areas of infectious diseases, auto-immune diseases, and central nervous system (CNS) disorders. Audience: Graduate 7. Propose adequate experimental assays to support drug development projects hypotheses, demonstrating the limitations and the actual output of different in vitro, cellular, and animal models' assays. Audience: Graduate Learning Outcomes: 1. Explain and apply the concepts, principles, and applications of the most commonly used biochemical and spectrophotometric assays used in drug development to quantify the activity of molecular targets and their modulators. Audience: Graduate 2. Recommend specific in vitro target assays based on the molecular target of choice and on the desired data output. Audience: Graduate 3. Compare and contrast cellular models, their applications and limitations, and propose assays that directly measure on-target activity. Audience: Graduate 4. Critique the use of various animal models when extrapolating pre-clinical data to clinical development. Audience: Graduate 5. Synthesize knowledge of biochemical, in vitro, and cellular assays to evaluate the validity, applications, and future developments of New Approach Methods (NAMs), according to the current FDA guidelines for animal use in research. Audience: Graduate 6. Analyze critically experimental approaches, assays outcomes, and their alignment to experimental hypothesis in drug development projects within the broad areas of infectious diseases, auto-immune diseases, and central nervous system (CNS) disorders. Audience: Graduate 7. Propose adequate experimental assays to support drug development projects hypotheses, demonstrating the limitations and the actual output of different in vitro, cellular, and animal models' assays. Audience: Graduate